Last Updated on March 16, 2024
Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to the pharmaceuticals products.
1. Drug Manufacturing License
Guidance on Establishment of Pharmaceutical Unit and Post License Changes
English ( 591 KB – PDF)
Draft for comments
2. Drug Registration
Guidance Document For Submission Of Application On FORM 5-F (CTD) For Registration Of Pharmaceutical Drug Products For Human Use .
English ( 444 KB – PDF)
Guidance on Preparation of Summary of Product Characteristics (SmPC)
English ( 386 KB – PDF)
Guidance on Labelling and Packing of Drugs
English ( 381 KB – PDF)
Guidance on Patient Information Leaflet (PIL)
English ( 363 KB – PDF)
Frequently asked questions about Form 5F (Common Technical Documents)
English ( 256 KB – PDF)
3. Post Approval Variations of Drugs
Post Registration Variation Guidelines For Pharmaceutical and Biological Products
English ( 735 KB – PDF)
4. Non Routine Registration pathways for Drug Registration
Priority Review and Accelerated Approval of Registration / Market Authorization
English ( 302 KB – PDF)
5. Reliance Mechanism
Reliance Mechanism in Regulatory processes, A DRAP’s approach on Good Reliance Practices
English ( 454 KB – PDF)
6. Appeals Against Regulatory Decisions
Guidelines for Filling an Appeal Against the Decisions of Statutory Bodies (e.g. Registration Board)
English ( 371 KB – PDF)